ES2640973T3 - Method of manufacturing a needle and needle - Google Patents
Method of manufacturing a needle and needle Download PDFInfo
- Publication number
- ES2640973T3 ES2640973T3 ES08170718.4T ES08170718T ES2640973T3 ES 2640973 T3 ES2640973 T3 ES 2640973T3 ES 08170718 T ES08170718 T ES 08170718T ES 2640973 T3 ES2640973 T3 ES 2640973T3
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- Spain
- Prior art keywords
- sleeve
- cannula
- needle
- length
- flange
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
- 238000004519 manufacturing process Methods 0.000 title description 9
- 238000000034 method Methods 0.000 claims abstract description 21
- 239000000463 material Substances 0.000 claims description 10
- 238000002788 crimping Methods 0.000 claims description 8
- 239000000853 adhesive Substances 0.000 claims description 7
- 230000001070 adhesive effect Effects 0.000 claims description 7
- 238000003466 welding Methods 0.000 description 25
- 210000004369 blood Anatomy 0.000 description 9
- 239000008280 blood Substances 0.000 description 9
- 238000001990 intravenous administration Methods 0.000 description 6
- 210000004204 blood vessel Anatomy 0.000 description 4
- 230000001012 protector Effects 0.000 description 4
- 230000008901 benefit Effects 0.000 description 3
- 239000012530 fluid Substances 0.000 description 3
- 230000036541 health Effects 0.000 description 3
- 239000002184 metal Substances 0.000 description 3
- 210000005036 nerve Anatomy 0.000 description 3
- 230000002093 peripheral effect Effects 0.000 description 3
- 210000003462 vein Anatomy 0.000 description 3
- 230000000712 assembly Effects 0.000 description 2
- 238000000429 assembly Methods 0.000 description 2
- 210000001124 body fluid Anatomy 0.000 description 2
- 239000010839 body fluid Substances 0.000 description 2
- 230000001681 protective effect Effects 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 208000030507 AIDS Diseases 0.000 description 1
- 206010069803 Injury associated with device Diseases 0.000 description 1
- 208000012266 Needlestick injury Diseases 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 229910045601 alloy Inorganic materials 0.000 description 1
- 239000000956 alloy Substances 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 238000005266 casting Methods 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 230000001506 immunosuppresive effect Effects 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 230000005541 medical transmission Effects 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 230000010412 perfusion Effects 0.000 description 1
- 210000005259 peripheral blood Anatomy 0.000 description 1
- 239000011886 peripheral blood Substances 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 229910000679 solder Inorganic materials 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 235000021476 total parenteral nutrition Nutrition 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
- B21C—MANUFACTURE OF METAL SHEETS, WIRE, RODS, TUBES OR PROFILES, OTHERWISE THAN BY ROLLING; AUXILIARY OPERATIONS USED IN CONNECTION WITH METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL
- B21C37/00—Manufacture of metal sheets, bars, wire, tubes or like semi-manufactured products, not otherwise provided for; Manufacture of tubes of special shape
- B21C37/06—Manufacture of metal sheets, bars, wire, tubes or like semi-manufactured products, not otherwise provided for; Manufacture of tubes of special shape of tubes or metal hoses; Combined procedures for making tubes, e.g. for making multi-wall tubes
- B21C37/08—Making tubes with welded or soldered seams
- B21C37/0815—Making tubes with welded or soldered seams without continuous longitudinal movement of the sheet during the bending operation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/3273—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel freely sliding on needle shaft without connection to syringe or needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3286—Needle tip design, e.g. for improved penetration
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
- B21G—MAKING NEEDLES, PINS OR NAILS OF METAL
- B21G1/00—Making needles used for performing operations
- B21G1/08—Making needles used for performing operations of hollow needles or needles with hollow end, e.g. hypodermic needles, larding-needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/329—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Mechanical Engineering (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Environmental & Geological Engineering (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Laser Surgery Devices (AREA)
- Dowels (AREA)
- Iron Core Of Rotating Electric Machines (AREA)
- Manufacturing Of Electric Cables (AREA)
Abstract
Un método para formar un elemento característico en una cánula en una posición fija predeterminada inmutable a lo largo de la longitud de la cánula, que comprende: proporcionar una cánula (10) que tiene un primer extremo (11), un segundo extremo (12), un eje (13), una longitud que se extiende desde el primer extremo al segundo extremo, y un diámetro exterior que se extiende sobre al menos una primera porción de la longitud; caracterizado por los pasos de: proporcionar un manguito (40) con un reborde proximal (144), un reborde distal (145), un diámetro interior, extendiéndose una longitud (47) de manguito desde el reborde proximal al reborde distal, y extendiéndose unos bordes desde el reborde proximal al reborde distal, formando así una rendija (50) que se extiende en una dirección de longitud del manguito, en el que el manguito (40) tiene un diámetro interior menor que el diámetro exterior de la primera porción de la cánula; situar el manguito (40) sobre la cánula (10) en la primera porción de la cánula en un ajuste de interferencia de tal manera que la rendija (50) se expanda para acomodar la cánula; y unir el manguito a la cánula con una unión mecánica adicional (60).A method of forming a characteristic element in a cannula in a predetermined fixed fixed position immutable along the length of the cannula, comprising: providing a cannula (10) having a first end (11), a second end (12) , an axis (13), a length that extends from the first end to the second end, and an outer diameter that extends over at least a first portion of the length; characterized by the steps of: providing a sleeve (40) with a proximal flange (144), a distal flange (145), an inner diameter, extending a sleeve length (47) from the flange proximal to the distal flange, and extending about edges from the flange proximal to the distal flange, thus forming a slit (50) extending in a direction of length of the sleeve, in which the sleeve (40) has an inner diameter smaller than the outer diameter of the first portion of the cannula; placing the sleeve (40) on the cannula (10) in the first portion of the cannula in an interference fit such that the slit (50) expands to accommodate the cannula; and attach the sleeve to the cannula with an additional mechanical connection (60).
Description
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DESCRIPCIONDESCRIPTION
Metodo para fabricar una aguja y aguja Campo de la InvencionMethod for manufacturing a needle and needle Field of the Invention
El objeto de la invencion esta relacionado con el campo de la terapia por perfusion. En particular, la invencion esta relacionada con una aguja introductora que tiene un reborde dispuesto a una distancia predeterminada de la punta de la aguja, y a un metodo para fabricar una aguja de este tipo.The object of the invention is related to the field of perfusion therapy. In particular, the invention is related to an introducer needle having a flange disposed at a predetermined distance from the needle tip, and to a method of manufacturing such a needle.
Antecedentes de la InvencionBackground of the Invention
Los cateteres, particularmente los cateteres intravenosos (IV), se utilizan para realizar la perfusion de un fluido, tal como una solucion salina normal, distintos medicamentos y nutricion parenteral total, en un paciente o para retirar sangre de un paciente. Los cateteres IV perifericos tienden a ser relativamente cortos y son del orden de aproximadamente 38,1 mm (1,5 pulgadas) de longitud. El tipo mas comun de cateter IV es un cateter IV periferico sobre la aguja. Como su nombre implica, un cateter sobre la aguja se monta sobre una aguja introductora que tiene una punta distal puntiaguda. El cateter y la aguja introductora se montan de manera que la punta distal de la aguja introductora se extienda mas alla de la punta distal del cateter, estando orientado el bisel de la aguja de manera que se separe de la piel del paciente.Catheters, particularly intravenous (IV) catheters, are used to perfuse a fluid, such as a normal saline solution, various medications and total parenteral nutrition, in a patient or to withdraw blood from a patient. Peripheral IV catheters tend to be relatively short and are of the order of approximately 38.1 mm (1.5 inches) in length. The most common type of IV catheter is a peripheral IV catheter over the needle. As the name implies, a catheter over the needle is mounted on an introducer needle that has a pointed distal tip. The catheter and the introducer needle are mounted so that the distal tip of the introducer needle extends beyond the distal tip of the catheter, the needle bevel oriented so that it separates from the patient's skin.
El conjunto de cateter y aguja introductora se inserta con un angulo pequeno a traves de la piel del paciente en el interior del vaso sangumeo periferico, es decir, un vaso sangumeo menor que no esta conectado directamente al corazon, sino que es una de las ramas de los vasos sangumeos centrales que se conectan directamente al corazon. Con el fin de verificar la colocacion adecuada del conjunto en el vaso sangumeo, el tecnico clmico confirma que hay un retorno de sangre en la aguja y en una camara de retorno situada en el extremo proximal de la aguja, que tfpicamente esta formada como parte del cubo de la aguja. Una vez que se ha confirmado la colocacion adecuada, el tecnico clmico aplica presion al vaso sangumeo apretando la piel del paciente sobre la punta distal de la aguja introductora y del cateter. La presion del dedo obstruye cualquier flujo sangumeo adicional a traves de la aguja introductora. El tecnico clmico retira la aguja introductora, dejando al cateter en su lugar, y une un dispositivo de manejo de fluidos al cubo del cateter. Una vez que la aguja introductora se ha retirado del cateter, la misma es un “elemento puntiagudo contaminado con sangre”, y debe ser manejada adecuadamente.The catheter and introducer needle assembly is inserted at a small angle through the patient's skin inside the peripheral blood vessel, that is, a smaller blood vessel that is not directly connected to the heart, but is one of the branches of the central blood vessels that connect directly to the heart. In order to verify the proper placement of the assembly in the blood vessel, the weather technician confirms that there is a return of blood in the needle and in a return chamber located at the proximal end of the needle, which typically is formed as part of the needle hub. Once the proper placement has been confirmed, the weather technician applies pressure to the blood vessel by squeezing the patient's skin over the distal tip of the introducer needle and the catheter. Finger pressure obstructs any additional blood flow through the introducer needle. The weather technician removes the introducer needle, leaving the catheter in place, and attaches a fluid handling device to the catheter hub. Once the introducer needle has been removed from the catheter, it is a “pointed element contaminated with blood”, and must be handled properly.
En los ultimos anos ha habido una gran preocupacion respecto a la contaminacion de los tecnicos clmicos con la sangre de un paciente y un reconocimiento de que “los elementos puntiagudos contaminados con sangre” deben ser desechados inmediatamente. Esta preocupacion se ha producido como consecuencia de la aparicion de enfermedades que en la actualidad son incurables y mortales, tales como el Smdrome de Deficiencia Inmunosupresora Adquirida (“SIDA”), que se puede transmitir por intercambio de fluidos corporales de una persona infectada a otra persona. De esta manera, el contacto con el fluido corporal de una persona infectada con HIV debe ser evitado. Como se ha indicado mas arriba, si se ha utilizado una aguja introductora para colocar un cateter en la vena de una persona infectada con HIV, la aguja introductora puede ser un vehmulo para la transmision de la enfermedad. Aunque los tecnicos clmicos son conocedores de la necesidad de manejar adecuadamente los “elementos puntiagudos contaminados con sangre”, en ciertos entornos medicos, tales como situaciones de emergencia o como resultado de falta de atencion o de cuidado, se pueden producir pinchazos de agujas con agujas introductoras contaminadas.In recent years there has been great concern regarding the contamination of the chemical technicians with the blood of a patient and an acknowledgment that "pointed elements contaminated with blood" should be discarded immediately. This concern has occurred as a result of the occurrence of diseases that are currently incurable and fatal, such as the Acquired Immunosuppressive Deficiency Smdrome ("AIDS"), which can be transmitted by exchanging body fluids from one infected person to another person. In this way, contact with the body fluid of a person infected with HIV should be avoided. As indicated above, if an introducer needle has been used to place a catheter in the vein of a person infected with HIV, the introducer needle may be a vehicle for disease transmission. Although the chemical technicians are aware of the need to properly handle the “pointed elements contaminated with blood”, in certain medical environments, such as emergency situations or as a result of lack of attention or care, needle sticks with needles can occur contaminated introducers.
Como un resultado del problema de los pinchazos de agujas accidentales con “elementos puntiagudos contaminados con sangre”, distintos protectores de agujas han sido desarrollados. Ejemplos de tales protectores se muestran en la Patente Norteamericana numero 6.004.294 y en la Solicitud de Patente Norteamericana numero 09/717.148 (presentada el 21 de noviembre de 2000). Estos protectores funcionan por la aplicacion de un elemento caractenstico, tal como una porcion del diametro agrandado, formada sobre la aguja. El medio de aplicacion puede tomar muchas formas, tal como una compuerta elastica forzada para entrar en contacto con la porcion de diametro agrandada de la aguja cuando la punta de la aguja se encuentra en el interior del protector. Debido al pequeno tamano de la aguja y a su estructura delicada, ha sido difmil proporcionar un elemento caractenstico que pueda soportar una fuerza adecuada sin afectar el funcionamiento de la misma aguja. Ademas, tales elementos caractensticos tradicionalmente han incluido una rampa, una superficie radiada o angulada que se extiende desde la superficie de la aguja, que puede crear dificultades para capturar la punta en el interior del protector o que puede producir que se ejerza una fuerza sobre la aguja en una direccion no axial.As a result of the problem of accidental needle sticks with "pointed elements contaminated with blood", different needle protectors have been developed. Examples of such protectors are shown in U.S. Patent No. 6,004,294 and in U.S. Patent Application No. 09 / 717,148 (filed November 21, 2000). These protectors work by the application of a characteristic element, such as a portion of the enlarged diameter, formed on the needle. The application means can take many forms, such as an elastic gate forced to come into contact with the enlarged portion of the needle diameter when the needle tip is inside the shield. Due to the small size of the needle and its delicate structure, it has been difficult to provide a characteristic element that can withstand adequate force without affecting the operation of the needle itself. In addition, such characteristic elements have traditionally included a ramp, a radiated or angled surface that extends from the surface of the needle, which may create difficulties in capturing the tip inside the shield or that may cause a force to be exerted on the needle in a non-axial direction.
Un metodo que se corresponde con el preambulo de la reivindicacion 1 se revela en el documento WO 01/68174.A method that corresponds to the preamble of claim 1 is disclosed in WO 01/68174.
El documento GB 472.952 A describe una aguja medica que soporta un casquillo de division que rodea la cana de la aguja. El casquillo esta rodeado por un manguito provisto de un tornillo de ajuste u otros medios de sujecion, con lo que el casquillo esta sujeto con precision sobre la cana. Por estos medios, el operador puede predeterminar con precision la profundidad del empuje de la aguja. Para hacer esto, el casquillo debe posicionarse correctamente por el operador. El casquillo no es una parte fija de la aguja.GB 472.952 A describes a medical needle that supports a split sleeve that surrounds the needle shaft. The bushing is surrounded by a sleeve provided with an adjustment screw or other fastening means, whereby the bushing is precisely attached to the shaft. By this means, the operator can precisely predetermine the depth of the needle thrust. To do this, the bushing must be positioned correctly by the operator. The cap is not a fixed part of the needle.
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Sumario de la InvencionSummary of the Invention
Es un objeto de la presente invencion proporcionar un metodo para fabricar una aguja que pueda emplearse con diversos dispositivos de proteccion disenados con seguridad.It is an object of the present invention to provide a method for manufacturing a needle that can be used with various protective devices designed safely.
El metodo para formar un elemento caractenstico en una canula, de acuerdo con la invencion, esta definido por la reivindicacion 1.The method of forming a characteristic element in a cannula, according to the invention, is defined by claim 1.
Es una ventaja de otro aspecto de la invencion proporcionar un metodo para fabricar una aguja que tiene un elemento caractenstico con un reborde en angulo recto.It is an advantage of another aspect of the invention to provide a method for manufacturing a needle having a characteristic element with a right angle flange.
Es una ventaja de otro aspecto de la presente invencion formar una aguja con un manguito asegurado a una canula en un lugar predeterminado y un metodo para asegurar el manguito a la canula en el lugar predeterminado.It is an advantage of another aspect of the present invention to form a needle with a sleeve secured to a cannula in a predetermined place and a method of securing the sleeve to the cannula in the predetermined place.
Una ventaja de aun otro aspecto de la presente invencion es proporcionar una tecnica para asegurar un elemento caractenstico en la aguja que tiene un reborde puntiagudo en angulo recto que pueda ser capturado facilmente por un medio de aplicacion en un protector de aguja, y una vez capturado, pueda dirigir las fuerzas desde el medio de aplicacion a la aguja en una direccion sustancialmente axial.An advantage of yet another aspect of the present invention is to provide a technique for securing a characteristic needle element that has a pointed flange at right angles that can be easily captured by means of application on a needle guard, and once captured. , can direct the forces from the means of application to the needle in a substantially axial direction.
De acuerdo con un aspecto de la invencion, se proporciona un metodo para formar un elemento caractenstico en una aguja. En particular, una canula metalica hueca tiene un primer extremo y un segundo extremo, y un diametro exterior sustancialmente constante que se extiende sobre, al menos, una porcion de su longitud. Se proporciona un manguito metalico anular que tiene un reborde proximal y un reborde distal. La longitud del manguito anular es menor que la longitud de la porcion de diametro constante de la canula. El manguito tiene un diametro interior aproximadamente igual a, o menor que, el diametro exterior de la porcion de diametro constante de la canula. Dos bordes se extienden axialmente a lo largo de la longitud del manguito, desde el reborde proximal al reborde distal, con lo cual definen una rendija. El manguito esta situado sobre la canula en la porcion de diametro exterior constante en un ajuste por interferencia. Se proporciona una union mecanica adicional para asegurar el manguito a la canula. Por ejemplo, el manguito puede estar soldado a la canula utilizando un soldador por laser en al menos un borde del manguito cerca de una cualquiera de la cara proximal o de la cara distal. Ademas, el manguito puede estar alternativamente engarzado o pegado a la canula. Segun otro aspecto de la invencion, se proporciona una aguja que se ha realizado segun este metodo.According to one aspect of the invention, a method is provided for forming a characteristic element in a needle. In particular, a hollow metal cannula has a first end and a second end, and a substantially constant outer diameter extending over at least a portion of its length. An annular metal sleeve having a proximal flange and a distal flange is provided. The length of the annular sleeve is less than the length of the constant diameter portion of the cannula. The sleeve has an inner diameter approximately equal to, or less than, the outer diameter of the constant diameter portion of the cannula. Two edges extend axially along the length of the sleeve, from the proximal flange to the distal flange, thereby defining a slit. The sleeve is located on the cannula in the constant outer diameter portion in an interference fit. An additional mechanical joint is provided to secure the sleeve to the cannula. For example, the sleeve can be welded to the cannula using a laser welder on at least one edge of the sleeve near any one of the proximal face or the distal face. In addition, the sleeve may alternatively be crimped or glued to the cannula. According to another aspect of the invention, a needle that has been made according to this method is provided.
Ciertas realizaciones de este aspecto de la invencion hacen que el reborde proximal sea perpendicular al eje de la canula o que el reborde distal sea perpendicular al eje de la canula. El manguito puede estar soldado a la canula en posicion proxima a ambas cara proximal y cara distal, o una soldadura de costura puede aplicarse a lo largo de la longitud del manguito. Ademas, el manguito puede estar alternativamente engarzado o pegado a la canula. El manguito se puede formar laminando una chapa metalica en una forma angular, tal como un cilindro, y a continuacion deslizandolo sobre la canula. Se puede formar una ventana en el manguito en una posicion predeterminada con respecto a la rendija y el manguito puede ser soldado a la canula en la ventana. Una ventana de este tipo se puede disponer en el manguito en una posicion a 180° de la rendija.Certain embodiments of this aspect of the invention make the proximal flange perpendicular to the axis of the cannula or that the distal flange is perpendicular to the axis of the cannula. The sleeve can be welded to the cannula in a position close to both proximal and distal faces, or a seam weld can be applied along the length of the sleeve. In addition, the sleeve may alternatively be crimped or glued to the cannula. The sleeve can be formed by rolling a metal sheet in an angular shape, such as a cylinder, and then sliding it over the cannula. A window can be formed in the sleeve in a predetermined position with respect to the slit and the sleeve can be welded to the cannula in the window. Such a window can be arranged in the sleeve in a 180 ° position of the slit.
Ciertas implementaciones de este aspecto de la invencion asumen que el manguito se suelda a la canula despues del engarce o que se emplea un adhesivo para unir el manguito a la canula. El uso de un adhesivo puede ser particularmente ventajoso para sujetar en su sitio el manguito antes de formar el engarce o la soldadura.Certain implementations of this aspect of the invention assume that the sleeve is welded to the cannula after crimping or that an adhesive is used to attach the sleeve to the cannula. The use of an adhesive can be particularly advantageous for holding the sleeve in place before forming the crimping or welding.
Breve descripcion de los dibujosBrief description of the drawings
La figura 1 es una vista en perspectiva en despiece ordenado de una canula y de un manguito de acuerdo con un aspecto de la invencion.Figure 1 is an exploded perspective view of a cannula and a sleeve according to an aspect of the invention.
La figura 2 es una vista en perspectiva de una canula y de un manguito de acuerdo con un aspecto de la invencion con una soldadura de costura.Figure 2 is a perspective view of a cannula and a sleeve according to an aspect of the invention with a seam weld.
La figura 3 es una vista en perspectiva despiezada de una canula y de un cateter sobre la aguja, de acuerdo con un aspecto de la invencion.Figure 3 is an exploded perspective view of a cannula and a catheter on the needle, in accordance with an aspect of the invention.
La figura 4 es una vista lateral recortada de la canula y el cateter de la figura 3.Figure 4 is a cutaway side view of the cannula and catheter of Figure 3.
La figura 5 es una vista en perspectiva de una canula y de un manguito de acuerdo con otro aspecto de la invencion.Figure 5 is a perspective view of a cannula and a sleeve according to another aspect of the invention.
La figura 6 es una vista en alzado lateral de la canula y del manguito de la figura 5.Figure 6 is a side elevation view of the cannula and sleeve of Figure 5.
La figura 7 es una vista en alzado superior de una canula y de un manguito de acuerdo con otro aspecto de la invencion.Figure 7 is a top elevational view of a cannula and a sleeve according to another aspect of the invention.
La figura 8 es una vista en alzado inferior de la canula y el manguito de la figura 7.Figure 8 is a bottom elevation view of the cannula and sleeve of Figure 7.
La figura 9 es una vista en perspectiva de un manguito aislado.Figure 9 is a perspective view of an insulated sleeve.
La figura 10 es una vista en alzado delantero del manguito de la figura 9.Figure 10 is a front elevation view of the sleeve of Figure 9.
La figura 11 es una vista en alzado lateral del manguito de la figura 9.Figure 11 is a side elevational view of the sleeve of Figure 9.
La figura 12 es una vista en alzado superior en una chapa utilizada para formar el manguito de la figura 9.Figure 12 is a top elevation view on a sheet used to form the sleeve of Figure 9.
La figura 13 es una vista en alzado superior de una canula y de un manguito de acuerdo con un aspecto que se encuentra fuera del alcance de la invencion.Figure 13 is a top elevational view of a cannula and a sleeve according to an aspect that is outside the scope of the invention.
La figura 14 es una vista en alzado lateral de la canula y el manguito de la figura 13.Figure 14 is a side elevational view of the cannula and the sleeve of Figure 13.
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La figura 15 es una vista lateral recortada de la canula y el manguito de la figura 13.Figure 15 is a cutaway side view of the cannula and sleeve of Figure 13.
La figura 16 es una vista en perspectiva de un manguito para utilizarse de acuerdo con aspectos de laFigure 16 is a perspective view of a sleeve for use in accordance with aspects of the
invencion.invention.
Descripcion detalladaDetailed description
Como se utiliza en la presente memoria descriptiva, la expresion “proximal” se refiere a una posicion en la aguja 1, la cual, durante la utilizacion normal, es la mas proxima al tecnico clmico que utiliza el dispositivo y la mas alejada del paciente en conexion con el cual se utiliza el dispositivo (lado derecho de la figura 4). En cambio, la expresion “distal” se refiere a una posicion en la aguja, la cual, durante el uso normal, es la mas alejada del tecnico clmico que utiliza el dispositivo y la mas cercana al paciente en relacion con el cual se utiliza el dispositivo (lado izquierdo en la figura 4).As used herein, the term "proximal" refers to a position in needle 1, which, during normal use, is closest to the weather technician using the device and the furthest from the patient in connection with which the device is used (right side of figure 4). In contrast, the expression "distal" refers to a position in the needle, which, during normal use, is the furthest from the weather technician using the device and the closest to the patient in relation to which the device is used. device (left side in figure 4).
En diversas etapas de la fabricacion de los conjuntos de aguja y durante el uso de las agujas, sena ventajoso tener un elemento caractenstico distintivo en la aguja 1 que se asegure en una posicion fija y que se oriente con respecto al resto de la aguja 1, particularmente la punta 14. Por ejemplo, un elemento caractenstico de este tipo podna ser utilizado para orientar la aguja 1 con respecto a un cubo o sujetador de aguja. Como consecuencia, la punta 14 de la aguja se encontrana tambien en una orientacion fija con respecto al sujetador. El prestador de cuidados sanitarios conocena inmediatamente de esta manera la orientacion de la punta 14 de la aguja simplemente agarrando el sujetador. Ademas, un elemento caractenstico de este tipo sena mas facilmente agarrable por maquinas disenadas para fabricar automaticamente agujas y conjuntos de cateter sobre la aguja. El elemento caractenstico podna utilizarse para aplicarse a un liston 101 en un cateter 100 (vease la figura 4), con lo cual se posiciona la aguja en una posicion particular en el interior del cateter y se garantiza que la punta 14 de la aguja se extiende fuera del cateter una distancia satisfactoria. Ademas, un elemento caractenstico de este tipo puede ser agarrado mas facilmente por un dispositivo de seguridad disenado para capturar la punta 14 de la aguja despues de su uso.At various stages of the manufacture of the needle assemblies and during the use of the needles, it will be advantageous to have a distinctive feature in the needle 1 that is secured in a fixed position and that is oriented with respect to the rest of the needle 1, particularly the tip 14. For example, a characteristic element of this type could be used to orient the needle 1 with respect to a hub or needle holder. As a consequence, the tip 14 of the needle will also be in a fixed orientation with respect to the fastener. The healthcare provider immediately knows in this way the orientation of the tip 14 of the needle simply by grasping the fastener. In addition, such a characteristic element is more easily grasped by machines designed to automatically manufacture needles and catheter assemblies on the needle. The characteristic element could be used to apply to a strip 101 in a catheter 100 (see Figure 4), whereby the needle is positioned in a particular position inside the catheter and it is guaranteed that the tip 14 of the needle extends outside the catheter a satisfactory distance. In addition, such a feature can be more easily grasped by a safety device designed to capture the tip 14 of the needle after use.
De acuerdo con un aspecto de la invencion, una aguja 1 incluye una canula 10 que tiene un casquillo o manguito 14 unido en una posicion fija predeterminada a lo largo de la longitud de la canula. Como se discutira adelante mas completamente, el manguito 40 esta dimensionado preferiblemente con un diametro interior que es menor que el diametro exterior de la canula. Como consecuencia, hay un ajuste por interferencia entre el manguito 40 y la canula que ayuda a mantener el manguito en su posicion predeterminada. Uniones mecanicas o enlaces 60 adicionales se pueden proporcionar para mantener mejor el manguito 40 en su posicion. Estando el manguito 40 en su posicion, la aguja 1 incluye un elemento caractenstico (que puede incluir el reborde proximal 44 y/o el reborde distal 45 del manguito, o el mismo manguito, o alguna otra estructura unida a o formada enterizamente con el manguito, tal como un apendice 80) que se puede utilizar con distintos propositos relacionados con la fabricacion y el uso de la aguja 1. Por ejemplo, una vez formada, la aguja 1 puede ser insertada en el interior de un cateter 100 para su insercion dentro del tejido de un paciente. Despues del uso, la aguja 1 puede ser retirada del cateter. A continuacion, la punta 14 de la aguja, puede ser capturada en el interior de un dispositivo de proteccion disenado para seguridad que agarra el elemento caractenstico, tal como se revela en la Patente Norteamericana numero 6.004.294 y en la Solicitud de Patente Norteamericana numero 09/717.148 incorporadas al presente documento por referencia.According to one aspect of the invention, a needle 1 includes a cannula 10 having a sleeve or sleeve 14 attached in a predetermined fixed position along the length of the cannula. As will be discussed more fully below, the sleeve 40 is preferably sized with an inner diameter that is smaller than the outer diameter of the cannula. As a consequence, there is an interference fit between the sleeve 40 and the cannula that helps keep the sleeve in its predetermined position. Additional mechanical joints or links 60 can be provided to better maintain the sleeve 40 in its position. With the sleeve 40 in position, the needle 1 includes a feature (which may include the proximal flange 44 and / or the distal flange 45 of the sleeve, or the same sleeve, or some other structure attached to or integrally formed with the sleeve, such as an appendix 80) that can be used for different purposes related to the manufacture and use of the needle 1. For example, once formed, the needle 1 can be inserted inside a catheter 100 for insertion into the tissue of a patient. After use, the needle 1 can be removed from the catheter. Next, the tip 14 of the needle can be captured inside a protective device designed for safety that seizes the characteristic element, as disclosed in US Patent No. 6,004,294 and in US Patent Application Number 09 / 717,148 incorporated herein by reference.
La canula 10 incluye un extremo proximal 11 y un extremo distal 12 que se extienden a lo largo de un eje 13. Tfpicamente, la canula tiene una forma cilmdrica. Preferiblemente, al menos una porcion 21 de la canula tiene un diametro exterior constante. Una punta biselada 14 esta situada en el extremo distal de la canula. La punta biselada puede estar formada por dos superficies biseladas, un bisel proximal 15 y un bisel distal 16 (vease la figura 2), que estan dispuestos con angulos diferentes respecto del eje de la canula para facilitar la introduccion en el interior de la vena del paciente. La canula incluye una superficie exterior 20 y una superficie interior 19. La superficie interior 19 define una cavidad central 17 que se extiende desde el extremo proximal de la canula al extremo distal, formando una abertura 23 de punta en el extremo distal.The cannula 10 includes a proximal end 11 and a distal end 12 extending along an axis 13. Typically, the cannula has a cylindrical shape. Preferably, at least one portion 21 of the cannula has a constant outside diameter. A beveled tip 14 is located at the distal end of the cannula. The beveled tip may be formed by two beveled surfaces, a proximal bevel 15 and a distal bevel 16 (see Figure 2), which are arranged at different angles with respect to the axis of the cannula to facilitate the introduction into the vein of the patient. The cannula includes an outer surface 20 and an inner surface 19. The inner surface 19 defines a central cavity 17 extending from the proximal end of the cannula to the distal end, forming a tip opening 23 at the distal end.
Una abertura 18 enrasada se encuentra situada en la pared de la canula 10, creando un trayecto de flujo de fluido desde la cavidad central 17 al exterior de la canula dentro del cateter 100. Preferiblemente, la abertura enrasada es proximal al manguito 40. El cateter esta aplicado operativamente a una camara enrasada 90. La camara enrasada simplemente puede ser el espacio anular alrededor de la aguja en el interior del cateter (vease la figura 4) o una camara separada situada en el cubo de la aguja. Durante el uso, este trayecto de flujo proporciona al prestador de cuidados sanitarios una indicacion visual de que la vena ha sido penetrada con exito debido a que una pequena cantidad de sangre circulara a traves de la abertura de la punta, a traves de la abertura enrasada y al interior de la camara enrasada en donde es visible al prestador de cuidados sanitarios. Como se muestra en la figura 4, el cateter es transparente de manera que la sangre en el espacio anular 90 sea visible al prestador de cuidados sanitarios.A flush opening 18 is located in the wall of the cannula 10, creating a fluid flow path from the central cavity 17 to the outside of the cannula within the catheter 100. Preferably, the flush opening is proximal to the sleeve 40. The catheter It is operatively applied to a flush chamber 90. The flush chamber can simply be the annular space around the needle inside the catheter (see Figure 4) or a separate chamber located in the needle hub. During use, this flow path provides the health care provider with a visual indication that the vein has been successfully penetrated because a small amount of blood circulates through the tip opening, through the flush opening and inside the flush chamber where it is visible to the healthcare provider. As shown in Figure 4, the catheter is transparent so that the blood in the annular space 90 is visible to the health care provider.
El casquillo o manguito 40 preferiblemente tiene una forma sustancialmente cilmdrica (vease la figura 9) formada por una superficie exterior 42, una superficie interior 43 y una longitud 47 que se extiende desde una cara distal 145 a una cara proximal 144. La superficie interior 43 define una cavidad interna 51. De manera importante, de acuerdo con ciertas realizaciones practicas de la invencion, el manguito 40 esta dimensionado para ajustarse apretadamente sobre la canula en un ajuste por interferencia. La longitud 47 del manguito 40 preferiblemente no es mas larga que la longitud de la porcion 21 de diametro constante de la canula. Como se puede ver en la figura 4, cuando el manguito 40 esta situado sobre la canula, la cara distal forma un reborde distal 45 y la cara proximal forma un rebordeThe bushing or sleeve 40 preferably has a substantially cylindrical shape (see Figure 9) formed by an outer surface 42, an inner surface 43 and a length 47 extending from a distal face 145 to a proximal face 144. The inner surface 43 defines an internal cavity 51. Importantly, according to certain practical embodiments of the invention, the sleeve 40 is sized to fit tightly over the cannula in an interference fit. The length 47 of the sleeve 40 preferably is not longer than the length of the constant diameter portion 21 of the cannula. As can be seen in Figure 4, when the sleeve 40 is located on the cannula, the distal face forms a distal flange 45 and the proximal face forms a flange
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proximal 44. Preferiblemente, el reborde distal y el reborde proximal son perpendiculares a la superficie exterior de la canula 10 y al eje 13 de la canula.proximal 44. Preferably, the distal flange and the proximal flange are perpendicular to the outer surface of the cannula 10 and to the axis 13 of the cannula.
Una rendija 50 esta formada en el manguito 40 y esta definida por dos bordes 41. Preferiblemente, la rendija se extiende axialmente a lo largo del manguito 40 desde la cara proximal 144 a la cara distal 145. La rendija tambien puede tener otras formas y todavfa practicar la invencion. En particular, la rendija puede extenderse alrededor del manguito 40 en forma espiral o en otras formas curvadas. Antes de situar el manguito 40 sobre la canula, los bordes son adyacentes, o casi adyacentes (vease la figura 5). Cuando el manguito 40 es forzado sobre la canula, los bordes se separan para acomodar el diametro exterior mayor de la canula en el interior de la cavidad interna 51.A slit 50 is formed in the sleeve 40 and is defined by two edges 41. Preferably, the slit extends axially along the sleeve 40 from the proximal face 144 to the distal face 145. The slit may also have other shapes and still practice the invention In particular, the slit may extend around the sleeve 40 in a spiral shape or in other curved shapes. Before placing the sleeve 40 on the cannula, the edges are adjacent, or almost adjacent (see Figure 5). When the sleeve 40 is forced on the cannula, the edges are separated to accommodate the larger outer diameter of the cannula inside the internal cavity 51.
El manguito 40 puede estar formado de cualquier manera, tal como por extrusion, colada o similar. Si el manguito 40 esta formado inicialmente como un cilindro completo, la rendija 50 se puede formar en el manguito, tal como por medio de corte, quemado, y otros. En una realizacion practica de la invencion, el manguito 40 esta formado por una chapa plana 46 (vease la figura 12). La chapa es laminada en una forma casi cilmdrica, llevando los bordes a que se junten y formando de esta manera la rendija. La chapa esta dimensionada de manera que la rendija se extienda sobre menos de 180° de arco a lo largo del diametro del manguito cuando el manguito esta situado sobre la canula. Preferiblemente, la rendija se extiende sobre 20° de arco o menos cuando el manguito esta situado sobre la canula. Se apreciara que la rendija puede ser mayor o menor y que todavfa se puede practicar la invencion. Ademas, en ciertas realizaciones practicas, la rendija puede estar formada como una ranura dispuesta en el manguito 40 que no se extiende completamente a traves del manguito 40 de forma radial (esto es, los bordes estan conectados por una cinta delgada antes de montar el manguito sobre la canula).The sleeve 40 may be formed in any way, such as by extrusion, casting or the like. If the sleeve 40 is initially formed as a complete cylinder, the slit 50 can be formed in the sleeve, such as by means of cutting, burning, and others. In a practical embodiment of the invention, the sleeve 40 is formed by a flat plate 46 (see Figure 12). The sheet is laminated in an almost cylindrical shape, leading the edges to be joined and thus forming the slit. The sheet is sized so that the slit extends over less than 180 ° arc along the diameter of the sleeve when the sleeve is located on the cannula. Preferably, the slit extends over 20 ° of arc or less when the sleeve is located on the cannula. It will be appreciated that the slit may be larger or smaller and that the invention can still be practiced. Also, in certain practical embodiments, the slit may be formed as a groove disposed in the sleeve 40 that does not extend completely through the sleeve 40 radially (that is, the edges are connected by a thin tape before mounting the sleeve on the cannula).
Una vez que se haya formado el manguito 40, este se desliza sobre el extremo distal 12 de la canula 10 y se situa en una posicion determinada sobre una porcion 21 de diametro constante de la canula. Preferiblemente, el manguito 40 esta situado a una distancia de la punta 14 de manera que la punta y el manguito puedan ser asegurados en el interior de un protector despues de su utilizacion, como se ha explicado en la patente Norteamericana Numero 6.004.294, incorporada en el presente documento por referencia, y en la Solicitud de Patente Norteamericana numero de serie 09/717.148, incorporada en el presente documento por referencia. Se apreciara que el manguito 40 puede estar situado en otras posiciones y todavfa practicar aspectos de la invencion. Ademas, el manguito 40 puede estar formado de otras maneras y situarse sobre la canula de formas diferentes y todavfa practicar aspectos de la invencion. Por ejemplo, la chapa plana 46 puede estar laminada directamente sobre la canula y asegurada en su posicion como se ha explicado en la presente memoria descriptiva.Once the sleeve 40 has been formed, it slides over the distal end 12 of the cannula 10 and is placed in a certain position on a portion 21 of constant diameter of the cannula. Preferably, the sleeve 40 is located at a distance from the tip 14 so that the tip and the sleeve can be secured inside a shield after use, as explained in US Pat. No. 6,004,294, incorporated in this document by reference, and in the US Patent Application serial number 09 / 717,148, incorporated herein by reference. It will be appreciated that sleeve 40 may be located in other positions and still practice aspects of the invention. In addition, the sleeve 40 may be formed in other ways and be placed on the cannula in different ways and still practice aspects of the invention. For example, the flat sheet 46 may be laminated directly on the cannula and secured in its position as explained herein.
Como se ha explicado mas arriba, el diametro de la cavidad interior 51 del manguito 40 es preferiblemente menor que el diametro de la superficie exterior 20 de la canula 10, creando un ajuste por interferencia mtimo entre el manguito y la canula. Los bordes 41 del manguito 40 se fuerzan a separarse para acomodar el diametro exterior de la canula. Si la cinta entra en contacto con los bordes, se rompe cuando la canula es forzada al interior de la cavidad interna. En cualquier caso, preferiblemente hay un contacto directo entre la superficie interior 43 del manguito 40 y la superficie exterior 20 de la canula cuando el manguito se situa sobre la canula.As explained above, the diameter of the inner cavity 51 of the sleeve 40 is preferably smaller than the diameter of the outer surface 20 of the cannula 10, creating an adjustment for minimal interference between the sleeve and the cannula. The edges 41 of the sleeve 40 are forced to separate to accommodate the outer diameter of the cannula. If the tape comes into contact with the edges, it breaks when the cannula is forced into the inner cavity. In any case, there is preferably a direct contact between the inner surface 43 of the sleeve 40 and the outer surface 20 of the cannula when the sleeve is placed on the cannula.
El ajuste por interferencia entre la superficie interior 43 del manguito 40 y la superficie exterior 20 de la canula impide el movimiento del manguito 40 a lo largo de la longitud de la canula bajo ciertas cargas. Ciertamente, el ajuste por interferencia por sf mismo puede proporcionar una resistencia adecuada al movimiento del manguito 40 para una aplicacion particular, de manera que el ajuste por interferencia puede considerarse como una union mecanica adecuada. Sin embargo, en ciertas circunstancias se deseara una mayor fuerza resistiva. En esas circunstancias, se proporciona una union mecanica adicional 60, asegurando el manguito 40 a la canula. Por ejemplo, el manguito 40 se puede soldar a la canula utilizando un soldador por laser. Como se representa en la figura 2, un haz de laser 301 de un dispositivo 300 de soldadura por laser, tal como un soldador por laser de Nd: Yag, modelo Luxstar LX50 puede ser dirigido a los puntos de contacto en el manguito 40. El manguito y la canula se encuentran en aplicacion ffsica directa en los puntos de contacto. Una soldadura de costura 160 puede ser creada entonces a lo largo de la rendija 60 suministrando un haz de laser en una serie de puntos sobre la longitud del manguito.Adjustment by interference between the inner surface 43 of the sleeve 40 and the outer surface 20 of the cannula prevents movement of the sleeve 40 along the length of the cannula under certain loads. Certainly, the interference fit itself can provide adequate resistance to the movement of the sleeve 40 for a particular application, so that the interference fit can be considered as a suitable mechanical joint. However, in certain circumstances a greater resistive force will be desired. In these circumstances, an additional mechanical union 60 is provided, securing the sleeve 40 to the cannula. For example, sleeve 40 can be welded to the cannula using a laser welder. As shown in FIG. 2, a laser beam 301 of a laser welding device 300, such as a Nd: Yag laser welder, model Luxstar LX50 can be directed to the contact points in the sleeve 40. The sleeve and cannula are in direct physical application at contact points. A seam weld 160 can then be created along the slit 60 by supplying a laser beam at a series of points over the length of the sleeve.
Tambien se pueden utilizar otras tecnicas de soldadura. Haciendo referencia a las figuras 7 y 8, dos de los puntos de contacto o puntos de soldadura 61 se encuentran situados a lo largo de los bordes 41 en la rendija 50, uno cerca del reborde proximal 44 y el otro cerca del reborde distal 45. El haz de laser se dirige a la union del borde y de la canula en la rendija. El laser funde el material del manguito 40 y la canula, la cual, a su vez, se enfna para formar una soldadura enteriza con el manguito 40 asf como con la canula, asegurandolos uno con la otra. Otros dos puntos de contacto o puntos de soldadura 64 se encuentran dispuestos en el lado opuesto del manguito 40, a 180° desde la rendija. De nuevo, estos puntos de soldadura se encuentran dispuestos cerca del reborde proximal 44 y del reborde distal 45. El haz de laser se dirige a la superficie exterior 42 del manguito 40, fundiendo a traves de la pared del manguito de manera que los haces fundan al menos alguna porcion de la superficie exterior 20 de la canula 10. Las porciones fundidas del manguito 40 y de la canula 10 se enfnan para formar una soldadura enteriza con el manguito, asf como con la canula, asegurandolos uno con la otra.Other welding techniques can also be used. Referring to Figures 7 and 8, two of the contact points or weld points 61 are located along the edges 41 in the slit 50, one near the proximal flange 44 and the other near the distal flange 45. The laser beam is directed to the junction of the edge and the cannula in the slit. The laser melts the material of the sleeve 40 and the cannula, which, in turn, cools to form an integral weld with the sleeve 40 as well as with the cannula, securing them with each other. Two other contact points or solder points 64 are arranged on the opposite side of the sleeve 40, 180 ° from the slit. Again, these welding points are arranged near the proximal flange 44 and the distal flange 45. The laser beam is directed to the outer surface 42 of the sleeve 40, melting through the wall of the sleeve so that the beams melt at least some portion of the outer surface 20 of the cannula 10. The molten portions of the sleeve 40 and the cannula 10 are cooled to form an integral weld with the sleeve, as well as with the cannula, securing them with each other.
Estas cuatro soldaduras pueden ser creadas dividiendo un unico haz de laser en cuatro haces, y aplicandolos a los puntos de soldadura deseados durante un periodo de tiempo controlado, que depende de las dimensiones y de losThese four welds can be created by dividing a single laser beam into four beams, and applying them to the desired welding points for a controlled period of time, which depends on the dimensions and the
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materiales que forman el manguito 40 y la canula 10, as^ como de la fuerza de resistencia deseada que debe ser soportada por la union mecanica 60. Se apreciara que otras tecnicas de soldadura, en particular otras tecnicas de soldadura por laser, pueden ser utilizadas y todavfa practicar aspectos de la invencion. Por ejemplo, la soldadura puede proporcionarse en posiciones distintas de la rendija. Actualmente, en una aplicacion preferente de la invencion, se forman dos soldaduras de costura 160 dispuestas a 180° una de otra, ninguna de las cuales esta situada a lo largo de la rendija. El haz de laser se suministra a la superficie del manguito y produce una soldadura, que une el manguito a la canula a lo largo de ambas costuras. Alternativa o adicionalmente, se puede proporcionar una ventana 48 en el manguito. La union mecanica 60 se puede formar mediante soldadura por puntos en el borde de la ventana (veanse las figuras 3 y 4).materials forming the sleeve 40 and the cannula 10, as well as the desired strength of resistance that must be supported by the mechanical joint 60. It will be appreciated that other welding techniques, in particular other laser welding techniques, can be used and still practice aspects of the invention. For example, welding can be provided in positions other than the slit. Currently, in a preferred application of the invention, two seam welds 160 formed 180 ° from each other are formed, none of which is located along the slit. The laser beam is supplied to the surface of the sleeve and produces a weld, which joins the sleeve to the cannula along both seams. Alternatively or additionally, a window 48 can be provided in the sleeve. The mechanical joint 60 can be formed by spot welding at the edge of the window (see Figures 3 and 4).
Las dimensiones y los materiales del manguito 40 y de la canula 10, asf como la operacion del soldador por laser, dependeran de la aplicacion particular para la aguja 1. Es preferido que el manguito 40 y la canula se formen de una aleacion similar para asegurar que se forme una union mecanica satisfactoria por la soldadura de laser u otra union mecanica. En una aplicacion de la invencion actual, la canula esta fabricada de acero inoxidable completamente duro 301 (o 302) y tiene un diametro exterior de entre 0,17 mm y 2,03 mm (0,007 y 0,080 pulgadas) (incluyendo aproximadamente 1,4 mm (0,055 pulgadas)). El manguito 40 esta formado de una chapa de acero inoxidable completamente duro 301 (o 302) aproximadamente de 0,05 mm (0,002 pulgadas) de grosor y aproximadamente de una longitud de 1,27 mm (0,050 pulgadas). Los puntos de soldadura son preferiblemente de aproximadamente 0,12 mm (0,005 pulgadas) hacia dentro desde los rebordes proximal y distal. Mas preferiblemente, el manguito 40 entra en contacto con la canula allf donde se aplica la soldadura. En cualquier caso, es preferido que haya una separacion no superior a 0,025 mm (0,0010 pulgadas) en un punto de soldadura deseado. El haz de laser es aplicado a los puntos de soldadura durante un periodo de 0,2 segundos a 100 Hz, y con una potencia de 30-50 KW. La soldadura resultante en el punto de soldadura es de aproximadamente 0,25 mm (0,010 pulgadas) de diametro y puede soportar una fuerza axial de aproximadamente 13,6 kg 22,7 kg (30-50 libras).The dimensions and materials of the sleeve 40 and the cannula 10, as well as the operation of the laser welder, will depend on the particular application for the needle 1. It is preferred that the sleeve 40 and the cannula be formed of a similar alloy to ensure that a satisfactory mechanical union be formed by laser welding or other mechanical union. In an application of the present invention, the cannula is made of completely hard stainless steel 301 (or 302) and has an outside diameter of between 0.17 mm and 2.03 mm (0.007 and 0.080 inches) (including approximately 1.4 mm (0.055 inch)). The sleeve 40 is formed of a completely hard stainless steel plate 301 (or 302) approximately 0.05 mm (0.002 inches) thick and approximately a length of 1.27 mm (0.050 inches). The weld points are preferably about 0.12 mm (0.005 inches) inwards from the proximal and distal flanges. More preferably, the sleeve 40 comes into contact with the cannula where welding is applied. In any case, it is preferred that there is a gap not exceeding 0.025 mm (0.0010 inches) at a desired weld point. The laser beam is applied to the welding points for a period of 0.2 seconds at 100 Hz, and with a power of 30-50 KW. The resulting weld at the weld point is approximately 0.25 mm (0.010 inches) in diameter and can withstand an axial force of approximately 13.6 kg 22.7 kg (30-50 pounds).
Haciendo referencia a las figuras 13-15, se revela otra forma de union mecanica. Unas muescas de engarce 70 estan formadas en la canula en posiciones deseadas, tales como en la porcion 21 de diametro por lo demas constante de la canula (constante, esto es, excluyendo las muescas de engarce). Preferiblemente, las muescas engarzadas no penetran en la pared de la canula. Sin embargo, las muescas engarzadas 70 pueden estar formadas como recortes en la pared de la canula. Ademas, la muesca enrasada 18 se puede utilizar como una muesca de engarce. El numero, posicion y forma de las muescas de engarce 70 se pueden seleccionar en base a la aplicacion particular de la aguja. Por ejemplo, se pueden utilizar dos muescas de engarce, dispuestas en lados opuestos de la canula en una posicion distal a la muesca enrasada 18 (vease la figura 15). El manguito 40 se forma y se desliza sobre la canula hasta que se disponga directamente sobre las muescas de engarce, capturando las muescas de engarce en el interior de la cavidad interna 51. A continuacion, el manguito 40 es engarzado dentro de las muescas de engarce 25, creando una aplicacion mecanica en la union 63 entre el manguito y la canula. El manguito 40 tambien puede asegurarse a la canula utilizando un material adhesivo 62 o puntos de soldadura 61. La utilizacion de un material adhesivo puede ser ventajosa, particularmente para mantener el manguito en posicion en la canula hasta que se haya completado el engarce o la soldadura.Referring to Figures 13-15, another form of mechanical union is revealed. Crimping notches 70 are formed in the cannula in desired positions, such as in the otherwise constant diameter portion 21 of the cannula (constant, that is, excluding crimp notches). Preferably, the crimped notches do not penetrate the cannula wall. However, the crimped notches 70 may be formed as cutouts in the cannula wall. In addition, the flush notch 18 can be used as a crimp notch. The number, position and shape of the crimping notches 70 can be selected based on the particular application of the needle. For example, two crimping notches can be used, arranged on opposite sides of the cannula in a position distal to the flush notch 18 (see Figure 15). The sleeve 40 is formed and slides over the cannula until it is arranged directly on the crimp notches, capturing the crimp notches inside the inner cavity 51. Next, the sleeve 40 is crimped into the crimp notches. 25, creating a mechanical application at junction 63 between the sleeve and the cannula. The sleeve 40 can also be secured to the cannula using an adhesive material 62 or weld points 61. The use of an adhesive material can be advantageous, particularly to keep the sleeve in position in the cannula until the crimping or welding is completed. .
Como se ha discutido mas arriba, el elemento caractenstico en la aguja 1, tal como el manguito 40, y/o sus rebordes proximal y distal, son simetricos preferiblemente respecto al eje del cateter. Se apreciara que el manguito 40 puede tener otras formas distintas y todavfa practicar la invencion. Por ejemplo, unos apendices o nervios 80 (vease la figura 16) pueden estar formados en el manguito 40, extendiendose radialmente hacia fuera o extendiendose axialmente desde el reborde distal o el reborde proximal a lo largo de la superficie de la canula. Tales apendices o nervios se pueden utilizar para orientar la canula (y, por lo tanto, la punta 14 de la aguja) con el cateter 100 (y de esta manera un cubo que es agarrado por el prestador de cuidados sanitarios). Ademas, tales apendices o nervios se pueden utilizar como un registro para observar y controlar la orientacion de la canula durante el proceso de fabricacion. Los apendices o nervios tambien se pueden disenar para que cooperen con distintas estructuras en un protector de aguja para capturar mejor la punta 14 de la aguja.As discussed above, the characteristic element in the needle 1, such as the sleeve 40, and / or its proximal and distal flanges, are preferably symmetrical with respect to the axis of the catheter. It will be appreciated that sleeve 40 may have other forms and still practice the invention. For example, appendages or ribs 80 (see Figure 16) may be formed in sleeve 40, extending radially outwardly or extending axially from the distal flange or proximal flange along the surface of the cannula. Such appendages or nerves can be used to orient the cannula (and, therefore, the tip 14 of the needle) with catheter 100 (and thus a bucket that is seized by the health care provider). In addition, such appendages or nerves can be used as a record to observe and control the orientation of the cannula during the manufacturing process. The appendages or nerves can also be designed to cooperate with different structures in a needle shield to better capture the tip 14 of the needle.
Ademas, como se ha explicado en la presente memoria descriptiva, la canula tiene una forma sustancialmente cilmdrica. Se apreciara que la canula puede tener otras formas y todavfa practicar aspectos de la invencion. Por ejemplo, la canula puede tener una seccion transversal oval de manera que el manguito 40 entre en contacto con la canula solamente a lo largo del eje principal del ovalo. En cambio, el manguito puede estar formado con una cavidad interna que tiene una seccion transversal oval de manera que entre en contacto con la superficie exterior 20 de la canula en el eje menor del ovalo. La union mecanica puede formarse entonces en esos puntos de contacto, por soldadura, usando un material adhesivo 62 o engarzando el manguito 40 dentro de una muestra en la canula.In addition, as explained herein, the cannula has a substantially cylindrical shape. It will be appreciated that the cannula may have other forms and still practice aspects of the invention. For example, the cannula may have an oval cross section so that the sleeve 40 contacts the cannula only along the main axis of the oval. Instead, the sleeve may be formed with an internal cavity that has an oval cross section so that it comes into contact with the outer surface 20 of the cannula on the minor axis of the oval. The mechanical joint can then be formed at those contact points, by welding, using an adhesive material 62 or by crimping the sleeve 40 into a sample in the cannula.
Es preferido que el manguito 40 entre realmente en contacto con la canula en el punto de soldadura durante la soldadura. Un contacto de este tipo se consigue preferiblemente por ajuste por interferencia entre el manguito 40 y la canula. Sin embargo, se apreciara que el manguito 40 puede estar dimensionado de manera que no haya ajuste por interferencia y practicar aspectos de la invencion. Por ejemplo, un material de soldadura puede estar dispuesto alrededor de la canula cuando el manguito 40 se desliza en posicion antes de la soldadura. Ventajosamente, un soldador que tambien funciona como material adhesivo puede ser utilizado. Si el diametro interno del manguito 40 es mayor que el diametro externo de la canula, habra un espacio entre la canula y el manguito que podna interferir conIt is preferred that sleeve 40 actually comes into contact with the cannula at the weld point during welding. Such a contact is preferably achieved by adjustment by interference between the sleeve 40 and the cannula. However, it will be appreciated that the sleeve 40 may be sized so that there is no interference fit and practice aspects of the invention. For example, a welding material may be arranged around the cannula when the sleeve 40 slides into position before welding. Advantageously, a welder that also functions as an adhesive material can be used. If the inner diameter of the sleeve 40 is larger than the outer diameter of the cannula, there will be a gap between the cannula and the sleeve that could interfere with
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una soldadura de laser satisfactoria. Para solucionar esta dificultad en esta situacion, el manguito 40 puede estar forzado en una direccion contra la superficie exterior 20 de la canula para conseguir un punto de contacto en el que se pueda realizar la soldadura. Ademas, otras tecnicas de soldadura pueden no requerir el posicionado ajustado del manguito 40 y de la canula para conseguir una soldadura satisfactoria. De hecho, en ciertas circunstancias, el manguito 40 puede ser suficientemente grueso para que suficiente material pueda ser fundido por el soldador por laser con el fin de efectuar una soldadura adecuada sin afectar la integridad del manguito.a satisfactory laser welding. To solve this difficulty in this situation, the sleeve 40 may be forced in a direction against the outer surface 20 of the cannula to achieve a point of contact where welding can be performed. In addition, other welding techniques may not require tight positioning of sleeve 40 and cannula to achieve satisfactory welding. In fact, under certain circumstances, the sleeve 40 may be thick enough that enough material can be melted by the laser welder in order to make a proper weld without affecting the integrity of the sleeve.
Como se ha explicado en la presente memoria descriptiva, se utilizan cuatro puntos de soldadura por puntos o dos soldaduras de costura. Cualquier numero de soldaduras y de puntos de soldadura puede ser utilizado como sea requerido para conseguir una union satisfactoria entre el manguito y la canula para una aplicacion dada. Ademas, los puntos de soldadura y las costuras pueden estar situados en otras posiciones y todavfa practicar aspectos de la invencion. Por ejemplo, el manguito 40 puede estar asegurado a la canula con una unica soldadura formada en el manguito en cualquier posicion, tal como una posicion alejada de la rendija. El punto de soldadura puede estar en la union del reborde proximal y/o del reborde distal con la superficie exterior 20 de la canula. La soldadura puede ser una lmea contigua unica que se extiende axialmente a lo largo de la longitud completa del manguito 40 o circunferencialmente alrededor del diametro del manguito.As explained herein, four spot welding points or two seam welding are used. Any number of welds and weld points can be used as required to achieve a satisfactory joint between the sleeve and the cannula for a given application. In addition, welding points and seams may be located in other positions and still practice aspects of the invention. For example, the sleeve 40 may be secured to the cannula with a single weld formed in the sleeve in any position, such as a position away from the slit. The welding point may be at the junction of the proximal flange and / or the distal flange with the outer surface 20 of the cannula. The weld may be a single contiguous line that extends axially along the entire length of the sleeve 40 or circumferentially around the diameter of the sleeve.
El manguito 40 esta situado preferiblemente a lo largo de la canula en un punto distal de la muesca enrasada 18. Se apreciara que el manguito puede estar situado en otras posiciones y todavfa practicar aspectos de la invencion. Por ejemplo, la muesca enrasada 18 puede estar situada entre el manguito 40 y la punta de la canula. Alternativamente, el manguito 40 puede estar situado en aplicacion con, o cubriendo parcialmente, la muesca enrasada 18. Ademas, la rendija puede estar orientada en posiciones diferentes con respecto a la muesca enrasada 18 y practicar aspectos de la invencion.The sleeve 40 is preferably located along the cannula at a distal point of the flush notch 18. It will be appreciated that the sleeve may be located in other positions and still practice aspects of the invention. For example, the flush notch 18 may be located between the sleeve 40 and the tip of the cannula. Alternatively, the sleeve 40 may be located in application with, or partially covering, the flush notch 18. In addition, the slit may be oriented in different positions with respect to the flush notch 18 and practice aspects of the invention.
El reborde proximal y el reborde distal forman preferiblemente superficies en angulo recto con la superficie exterior 20 de la canula. Se apreciara que los rebordes pueden tener formas distintas y todavfa practicar aspectos de la invencion. Por ejemplo, el reborde puede estar provisto de un recorte en la superficie de la canula, creando una brecha que se puede aplicar a ciertos tipos de mecanismos de agarre contenidos en el interior de protectores. Ademas, la cara proximal 144 y la cara distal 145 pueden tener superficies curvadas o con muescas, dependiendo de la aplicacion particular de la invencion.The proximal flange and the distal flange preferably form surfaces at right angles to the outer surface 20 of the cannula. It will be appreciated that the flanges may have different shapes and still practice aspects of the invention. For example, the flange may be provided with a cut in the surface of the cannula, creating a gap that can be applied to certain types of gripping mechanisms contained within protectors. In addition, the proximal face 144 and the distal face 145 may have curved or notched surfaces, depending on the particular application of the invention.
Aunque la invencion se ha descrito en la presente memoria descriptiva con referencia a una aguja 1 utilizada con un cateter IV periferico y un protector de seguridad, se entiende que la invencion es aplicable a otras agujas, tales como agujas hipodermicas, agujas epidurales y otras. Ademas, aunque esta invencion es satisfecha por realizaciones en muchas formas diferentes, realizaciones preferidas de la invencion se muestran en los dibujos y se describen en detalle en la presente memoria descriptiva. El alcance de la invencion esta definido por las reivindicaciones adjuntas.Although the invention has been described herein with reference to a needle 1 used with a peripheral catheter IV and a safety guard, it is understood that the invention is applicable to other needles, such as hypodermic needles, epidural needles and others. In addition, although this invention is satisfied by embodiments in many different forms, preferred embodiments of the invention are shown in the drawings and are described in detail herein. The scope of the invention is defined by the appended claims.
Claims (7)
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-
2002
- 2002-05-01 US US10/137,464 patent/US6914212B2/en not_active Expired - Lifetime
-
2003
- 2003-04-24 BR BRPI0309626A patent/BRPI0309626B8/en not_active IP Right Cessation
- 2003-04-24 ES ES08170718.4T patent/ES2640973T3/en not_active Expired - Lifetime
- 2003-04-24 AT AT03718515T patent/ATE416805T1/en not_active IP Right Cessation
- 2003-04-24 AU AU2003221775A patent/AU2003221775A1/en not_active Abandoned
- 2003-04-24 ES ES03718515T patent/ES2316744T3/en not_active Expired - Lifetime
- 2003-04-24 EP EP08170718.4A patent/EP2055335B1/en not_active Expired - Lifetime
- 2003-04-24 EP EP03718515A patent/EP1503817B1/en not_active Expired - Lifetime
- 2003-04-24 CN CNB038099039A patent/CN100430102C/en not_active Expired - Lifetime
- 2003-04-24 DE DE60325202T patent/DE60325202D1/en not_active Expired - Lifetime
- 2003-04-24 JP JP2004500953A patent/JP4384974B2/en not_active Expired - Lifetime
- 2003-04-24 WO PCT/US2003/012625 patent/WO2003092772A2/en active Application Filing
- 2003-12-10 US US10/732,025 patent/US7002098B2/en not_active Expired - Lifetime
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AU2003221775A1 (en) | 2003-11-17 |
EP1503817B1 (en) | 2008-12-10 |
BRPI0309626B8 (en) | 2021-06-22 |
WO2003092772A3 (en) | 2004-03-04 |
BR0309626B1 (en) | 2014-06-03 |
EP1503817A2 (en) | 2005-02-09 |
CN100430102C (en) | 2008-11-05 |
US6914212B2 (en) | 2005-07-05 |
EP2055335B1 (en) | 2017-06-21 |
CN1649639A (en) | 2005-08-03 |
BR0309626A (en) | 2005-03-08 |
ES2316744T3 (en) | 2009-04-16 |
EP2055335A2 (en) | 2009-05-06 |
DE60325202D1 (en) | 2009-01-22 |
ATE416805T1 (en) | 2008-12-15 |
US7002098B2 (en) | 2006-02-21 |
JP4384974B2 (en) | 2009-12-16 |
JP2005523777A (en) | 2005-08-11 |
US20030205843A1 (en) | 2003-11-06 |
US20040118902A1 (en) | 2004-06-24 |
EP2055335A3 (en) | 2009-07-29 |
WO2003092772A2 (en) | 2003-11-13 |
AU2003221775A8 (en) | 2003-11-17 |
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